Pharmacologic Treatment Augmentation in Chronic Depression

Summary

To enroll in this clinical trial, prospective participants must meet stringent criteria. The participants need to fall within the age range of 18 to 64 and exhibit chronic depression at therapy resistance stage 2. This stage signifies that the participants have undergone unsuccessful treatment with at least two different antidepressants, despite adequate dosage and duration. Moreover, the participants should have engaged in at least 12 sessions of psychotherapy without experiencing significant relief from depressive symptoms. Additionally, participants must demonstrate the cognitive capacity to provide informed consent.

Upon expressing interest in the study and consenting to participate, individuals undergo a thorough screening process. This screening encompasses a comprehensive clinical interview to assess medical and psychiatric history, as well as various medical tests. These tests include physical examinations, blood draws (which may include pregnancy tests for female participants), and electrocardiograms (ECGs) to evaluate heart function. Following the screening, participants are randomly assigned to one of three different treatment groups (Ketamine +TAU; Ketamine+CBASP, Placebo+CBASP).

The study protocol involves a combination of psychotherapeutic treatment and either ketamine infusions or placebo. Throughout the study period, participants are subject to regular data collection, including psychological assessments, blood samples, and magnetic resonance imaging (MRI) scans. Participants' responses to treatment, as well as any changes in symptoms or side effects, are closely monitored.

After completing the study, participants are offered follow-up therapy as part of standard care. MRI scans are conducted to examine changes in brain activity associated with treatment response and depressive symptomatology, particularly focusing on alterations in neural circuitry and thought processes. Additionally, participants are encouraged to report any changes in medication regimen or other treatments received during the study period.

Conditions

• Major Depressive Disorder

Interventions

DRUG

Ketamine

Two ketamine hydrochloride (Ketamin Inresa 2 ml) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Ketamine hydrochloride (Ketamin Inresa 2 ml) is applied continuously over a time span of 40 minutes with a subanesthetic dosage of 0.5 mg per kg body weight.

DRUG

Placebo

Two times placebo (Isotone E NaCL 0.9 %) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Placebo is applied continuously over a time span of 40 minutes.

BEHAVIORAL

CBASP

In addition to standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements, patients in the CBASP conditions receive one CBASP group session (50 min) per week for 12 weeks. The single sessions (one 50 min and one 25 min per week) contents are CBASP-specific.

BEHAVIORAL

TAU

Standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements.

Sponsors & Collaborators

• German Center for Mental Health

  collaborator UNKNOWN

• University Hospital Tuebingen

  lead OTHER

Principal Investigators

• Martin Walter, Prof. Dr. · Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie

• Andreas J Fallgatter, Prof. Dr. · Universitätsklinikum Tübingen - Klinik für Psychiatrie und Psychotherapie

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-29

Primary Completion

2026-05-31

Completion

2026-07-31

Countries

• Germany

Study Locations